Ibuprofen NDC 53746-137

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-137Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0137Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
53746-137-01	53746013701	100 TABLET in 1 BOTTLE (53746-137-01)Marketed from Jan 5, 2009
53746-137-05	53746013705	500 TABLET in 1 BOTTLE (53746-137-05)Marketed from Jan 5, 2009
53746-137-30	53746013730	30 TABLET in 1 BOTTLE (53746-137-30)Marketed from Jan 5, 2009
53746-137-50	53746013750	50 TABLET in 1 BOTTLE (53746-137-50)Marketed from Jan 5, 2009
53746-137-60	53746013760	60 TABLET in 1 BOTTLE (53746-137-60)Marketed from Jan 5, 2009
53746-137-90	53746013790	90 TABLET in 1 BOTTLE (53746-137-90)Marketed from Jan 5, 2009

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Ibuprofen
Generic name (nonproprietary): ibuprofen
Active ingredients: Ibuprofen — 800 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 071935
Marketing start: Jan 5, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 53746-137_32dbe366-3f8b-4ace-9ce4-a9b695c58d30SPL ID 32dbe366-3f8b-4ace-9ce4-a9b695c58d30SPL set ID 75d963b9-3675-44ff-bc6b-83461bed1b67RxCUI 197807UNII WK2XYI10QMUPC 0353746137012
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N453746013701 followed by a unit qualifier and the quantity

Package 53746-0137-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jul 18, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS ]. Ibuprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets are indicated for relief of mild to moderate pain. Ibuprofen Tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets in children have not been conducted.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)